Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00517400
First received: August 16, 2007
Last updated: July 27, 2011
Last verified: July 2010
  Purpose

Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).

Comparing real to sham treatment.


Condition Intervention Phase
Post Traumatic Stress Disorder
Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • CAPS SCORE [TOTAL, INTRUSION]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exposure-Stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil
Active Comparator: Sham exposure - Real stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil
Active Comparator: Exposure - Sham Stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD diagnosis per DSM IV

Exclusion Criteria:

  • Schizophrenia
  • Bipolar I
  • severe Axis II diagnosis
  • risk factors to convulsions
  • drug / alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517400

Locations
Israel
Psychiatric department, Hadassah-Hebrew universityMedical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Moshe Isserles, MD, MSc Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Moshe Isserles, MD, MSc, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00517400     History of Changes
Other Study ID Numbers: 364/3.8.07(HMO)
Study First Received: August 16, 2007
Last Updated: July 27, 2011
Health Authority: Israel: Ministry of Health, Health Technology and Infrastructure Administration, Medical Device Department

Keywords provided by Hadassah Medical Organization:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014